Blood Pressure Monitor for High Blood Pressure

Recruiting in Palo Alto (17 mi)

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Aktiia SA

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This study, with N = 85 participants minimum over 3 visits spread over 23 hours, has been designed to assess the accuracy and precision of the Blood Pressure and pulse rate values as generated by Aktiia.product-G0 for up to 23 hours after initialization in a cohort of subjects representative of the US population. For the study, subjects will be asked to stay seated while measurements are taken at different timepoints.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are taking a prescription blood thinner, you cannot participate in the study.

What data supports the idea that Blood Pressure Monitor for High Blood Pressure is an effective treatment?

The available research does not provide any data supporting the effectiveness of the Blood Pressure Monitor for High Blood Pressure as a treatment for high blood pressure. The studies mentioned focus on measuring eye pressure and do not relate to blood pressure monitoring or its effectiveness in treating high blood pressure. ^{1 2 3 4 5}

What safety data is available for the Aktiia blood pressure monitor?

The Aktiia blood pressure monitor, including its various versions like the Aktiia Bracelet and Aktiia Spot-check Optical Blood Pressure Monitoring Device, has undergone several validation studies. These studies have assessed its accuracy and precision in measuring blood pressure across different body positions and compared it to traditional methods. The device has been validated using protocols like the extended ISO 81060-2 and ANSI/AAMI/ISO 81060-2:2013 standards. Results indicate that the Aktiia monitor provides accurate blood pressure estimates comparable to traditional ambulatory blood pressure monitors, although precision can vary with body position. These studies suggest that the device is safe and effective for monitoring blood pressure in real-life conditions. ^{6 7 8 9 10}

Is the Aktiia Bracelet a promising treatment for high blood pressure?

Yes, the Aktiia Bracelet is a promising treatment for high blood pressure. It is a wearable device that can accurately monitor blood pressure in different body positions over time. This makes it useful for tracking blood pressure in real-life situations, which can help in better understanding and managing high blood pressure. ^{6 7 8 11 12}

Research Team

Eligibility Criteria

This trial is for at least 85 adults with high blood pressure, representative of the US population. Participants will need to be available for 8 visits over a day and stay seated during measurements.

Inclusion Criteria

Participants must be able to provide an informed consent to participate

I am willing and able to follow the study rules and come back for a visit on day 2.

Participant or witness must be able to read or write in English

Exclusion Criteria

An upper arm circumference < 22cm or > 42cm

Any subject that, in the opinion of the investigator, does not exhibit any phenotype relevant to the objectives of this study

Any condition or circumstance that, in the opinion of the investigator, may preclude study completion, interfere with accurate data collection, bias the results

Treatment Details

Interventions

• Aktiia Spot-check Optical Blood Pressure Monitoring Device (Behavioural Intervention)

Trial Overview The study tests the Aktiia Spot-check Optical Blood Pressure Monitoring Device's accuracy in measuring blood pressure and pulse rate against standard methods, over a period of up to 23 hours.

Participant Groups

Group I: Aktiia.product-G0 device under test Experimental Treatment 1 Intervention

Subjects will be asked to stay seated while blood pressure and pulse rate measurements are taken at different timepoints with the device under test and references.

Who Is Running the Clinical Trial?

Aktiia SA

Lead Sponsor

Trials

12

Recruited

23,600+

Findings from Research

A clinical comparison involving 51 veterans showed that the Schiotz tonometer provides comparable intraocular pressure (IOP) measurements to the standard Perkins applanation tonometer, with strong correlation coefficients ranging from +0.68 to +0.85.

The Schiotz tonometer is a more portable and cost-effective alternative for IOP screening, making it a viable option for use in outpatient clinics, nursing homes, and hospitals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Portable tonometers: a clinical comparison of applanation and indentation devices. Chiara, GF., Semes, LP., Potter, JW., et al.[2006]

A study of 110 eyes found a significant correlation between ophthalmic artery pressure and brachial arterial pressure, indicating that measurements of these two pressures are related.

The mean systolic ophthalmic artery pressure was 114.5 mmHg, and interestingly, in some cases, the ophthalmic pressure exceeded the brachial pressure, suggesting potential ocular-vascular reflexes that could affect pressure readings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Measurement of arterial tension at the eye with the Stepanik arteriotonograph (author's transl)]. DaSilva, FA., Krieglstein, GK., von Collani, E.[2009]

In a study involving 30 patients with thyroid-associated ophthalmopathy, both the non-contact tonometer (NCT) and the Goldmann applanation tonometer (GAT) provided similar measurements of intraocular pressure (IOP) and mean ocular perfusion pressure (MOPP), indicating that NCT is a reliable alternative for monitoring these parameters.

The diagnostic efficacy of both tonometers was found to be equivalent, with 100% sensitivity and high specificity, suggesting that NCT could be a less invasive option for long-term monitoring in patients with TAO.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Two Tonometers in the Evaluation of 24-Hour Intraocular Pressure and Mean Ocular Perfusion Pressure in Patients with Thyroid-Associated Ophthalmopathy. Liu, W., Zhou, Y., Hu, X., et al.[2022]

In a study involving 5 eyes with Boston type 1 keratoprosthesis, the Schiotz tonometer provided significantly more accurate intraocular pressure (IOP) measurements compared to the Tono-pen, with lower median absolute errors at both the temporal sclera and corneoscleral limbus.

The findings suggest that clinicians should consider using the Schiotz tonometer for measuring IOP in patients with keratoprosthesis, as it demonstrated higher accuracy compared to the Tono-pen and the gold standard digital manometry.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Schiotz tonometry accurately measures intraocular pressure in Boston type 1 keratoprosthesis eyes. Estrovich, IE., Shen, C., Chu, Y., et al.[2022]

The Icare ic200 tonometer tends to overestimate intraocular pressure (IOP) compared to the Perkins tonometer, especially in patients with IOP greater than 19 mm Hg and those with corneal opacity, based on a study of 194 eyes from 105 pediatric glaucoma patients.

The differences in IOP measurements were more pronounced in eyes with scarred corneas, indicating that corneal clarity and thickness can significantly affect the accuracy of IOP readings between these two devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Evaluation of Rebound and Perkins Tonometers in Pediatric Glaucoma With Varied Corneal Characteristics. Angmo, D., Ramesh, P., Mahalingam, K., et al.[2023]

The Aktiia Bracelet, a wearable device, accurately estimates blood pressure (BP) across various common body positions, showing only minor differences compared to traditional auscultatory measurements in a study of 91 patients over 4 weeks.

This technology has the potential to enhance the phenotyping of hypertension in real-life conditions, which could lead to better public health interventions, although further studies are needed to confirm its prognostic value for cardiovascular events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of the optical Aktiia bracelet in different body positions for the persistent monitoring of blood pressure. Sola, J., Vybornova, A., Fallet, S., et al.[2022]

The Aktiia initialization oscillometric upper-arm cuff device demonstrated high accuracy in measuring blood pressure, with mean differences of only 1.3 mmHg for systolic and -0.2 mmHg for diastolic pressure compared to a standard mercury sphygmomanometer.

The device meets the ANSI/AAMI/ISO 81060-2:2013 standards for blood pressure monitoring, indicating it is safe and reliable for use in home settings for the general population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of the Aktiia blood pressure cuff for clinical use according to the ANSI/AAMI/ISO 81060-2:2013 protocol. Alexandre, J., Tan, K., Almeida, TP., et al.[2023]

The Aktiia Bracelet, a noninvasive optical blood pressure monitor, demonstrated good accuracy in measuring blood pressure over a month-long study with 86 participants, meeting the ISO81060-2 validation criteria.

The device showed a mean difference of only 0.46 mmHg for systolic blood pressure and 0.39 mmHg for diastolic blood pressure compared to standard measurements, indicating its potential reliability for regular blood pressure monitoring in adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood pressure from the optical Aktiia Bracelet: a 1-month validation study using an extended ISO81060-2 protocol adapted for a cuffless wrist device. Vybornova, A., Polychronopoulou, E., Wurzner-Ghajarzadeh, A., et al.[2023]

In a study involving 52 patients over a 12-week cardiac rehabilitation program, the cuffless Aktiia monitor provided daytime blood pressure measurements that were comparable to those from a traditional ambulatory BP monitor, showing no significant differences in systolic blood pressure.

The Aktiia monitor demonstrated a marginally non-significant bias in diastolic blood pressure, suggesting it may be a reliable alternative for continuous blood pressure monitoring in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aktiia cuffless blood pressure monitor yields equivalent daytime blood pressure measurements compared to a 24-h ambulatory blood pressure monitor: Preliminary results from a prospective single-center study. Almeida, TP., Cortés, M., Perruchoud, D., et al.[2023]

The study proposes a new experimental protocol for validating cuffless wrist blood pressure monitors, addressing challenges in real-world settings, such as different body postures and hydrostatic pressure changes.

Testing of the Aktiia Bracelet showed it can accurately estimate blood pressure in sitting and lying positions, indicating its potential for effective home monitoring without the discomfort of traditional cuffs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are cuffless devices challenged enough? Design of a validation protocol for ambulatory blood pressure monitors at the wrist: the case of the Aktiia Bracelet. Sola, J., Vybornova, A., Fallet, S., et al.[2020]

The Oregon Scientific BPU 330 blood pressure monitor was validated for accuracy using the International Protocol, showing that it can reliably measure blood pressure in adults, with most readings falling within acceptable ranges compared to a mercury sphygmomanometer.

Out of 52 participants, the device passed validation phases, demonstrating that it is suitable for self-monitoring of blood pressure, making it a safe option for consumers looking to manage their health at home.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of the Oregon Scientific BPU 330 for self-monitoring of blood pressure according to the International Protocol. Li, L., Zhang, X., Yan, C., et al.[2021]

The PG-800A36 automatic wrist blood pressure monitor was validated through rigorous testing with 118 participants, meeting the standards set by both the European Society of Hypertension and the British Hypertension Society.

It demonstrated high accuracy in measuring blood pressure, with average differences from standard measurements well within acceptable limits, making it a reliable option for self-monitoring blood pressure in the general population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of the Pangao PG-800A36 automatic wrist blood pressure monitor according to the European Society of Hypertension and the British Hypertension Society protocols. Zhao, H., Qiao, W., Zhang, R., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Portable tonometers: a clinical comparison of applanation and indentation devices. [2006]

2. Germany pubmed.ncbi.nlm.nih.gov

[Measurement of arterial tension at the eye with the Stepanik arteriotonograph (author's transl)]. [2009]

3. United States pubmed.ncbi.nlm.nih.gov

Comparison of Two Tonometers in the Evaluation of 24-Hour Intraocular Pressure and Mean Ocular Perfusion Pressure in Patients with Thyroid-Associated Ophthalmopathy. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Schiotz tonometry accurately measures intraocular pressure in Boston type 1 keratoprosthesis eyes. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Comparative Evaluation of Rebound and Perkins Tonometers in Pediatric Glaucoma With Varied Corneal Characteristics. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Validation of the optical Aktiia bracelet in different body positions for the persistent monitoring of blood pressure. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Validation of the Aktiia blood pressure cuff for clinical use according to the ANSI/AAMI/ISO 81060-2:2013 protocol. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Blood pressure from the optical Aktiia Bracelet: a 1-month validation study using an extended ISO81060-2 protocol adapted for a cuffless wrist device. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Aktiia cuffless blood pressure monitor yields equivalent daytime blood pressure measurements compared to a 24-h ambulatory blood pressure monitor: Preliminary results from a prospective single-center study. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Are cuffless devices challenged enough? Design of a validation protocol for ambulatory blood pressure monitors at the wrist: the case of the Aktiia Bracelet. [2020]

11. New Zealand pubmed.ncbi.nlm.nih.gov

Validation of the Oregon Scientific BPU 330 for self-monitoring of blood pressure according to the International Protocol. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Validation of the Pangao PG-800A36 automatic wrist blood pressure monitor according to the European Society of Hypertension and the British Hypertension Society protocols. [2019]